Scan Through SUDA’s Key Operational Achievements in FY 2019-2020

Summary

• SUDA reported key operational achievements for FY 2019-2020.
• The Company finalised a key agreement with Cann Pharma Australia during the year.
• The financial year also saw the signing of three significant agreements with Sanofi, Ordesa and MTPK by the Company.
• Post the financial year, SUDA attained TGA approval for ZolpiMist^TM and raised ~$3.56 million via entitlement offer and ~$0.5 million via Placement.

In its latest update, Australia-based oro-mucosal drug delivery firm SUDA Pharmaceuticals Limited (ASX:SUD) has released its preliminary final report for 12-months ended 30^th June 2020.

SUDA is an international leader in reformulating and delivering drugs via the oral mucosa. The Company uses its exclusive OroMist^® technology to create low-risk oral sprays. SUDA boasts a robust portfolio of assets, comprising ZolpiMist^TM (insomnia), Anagrelide (solid tumours with increased platelet levels) and Sumatriptan (migraine).

During the last financial year, SUDA observed several significant developments with regards to ZolpiMist^TM and other OroMist^® assets, as demonstrated in the below figure:

Let us quickly take a closer look at each of these operational developments below:

October 2019: Agreement with Cann Pharma

In late-October 2019, SUDA concluded a Product Development, Licence and Supply Agreement with Australian player, Cann Pharmaceutical Australia Ltd (CPA). The agreement was targeted at the development of a novel oral spray of pharma-grade cannabinoid derivatives for treating drug resistant epilepsy, melanoma and motion sickness across the world.

SUDA notified that subsequent to the completion of the feasibility study, which is to be fully financed by CPA, both SUDA and CPA will jointly determine further product development costs, which will also be fully funded by CPA.

December 2019: Agreements with Ordesa and Sanofi

In December 2019, SUDA signed two important agreements, with a Spanish pharmaceutical company Laboratorios Ordesa, S.L., and SANOFI-AVENTIS GROUPE.

SUDA entered into a fully funded, feasibility study and option agreement with Ordesa on 5^th December 2019 to co-develop a major consumer product for the paediatric market. SUDA expects this product to benefit from an enhanced patient delivery route and it may also benefit from the OroMist^® technology’s superiority in speed of onset of action and less drug being required.

Moreover, SUDA entered into a fully funded feasibility study with Sanofi on 9^th December 2019 to assess the feasibility of OroMist^® Technology and Sanofi’s designated active ingredient.

To Read More About These Agreements, Click Here!

March 2020: License and Supply agreement with MTPK; Update on ArTiMist^®

In March 2020, the Company signed an exclusive license agreement with MTPK or Mitsubishi Tanabe Pharma Korea for the supply of its core product, ZolpiMist^TM for South Korea. In relation to this agreement, SUDA has received an upfront payment of USD 100k and will attain commercial milestone payments of USD 300k on the basis of MTPK achieving sales targets.

The Company also placed its ArTiMist^® program on hold in March this year following the Therapeutic Goods Administration’s (TGA) denial on marketing approval of ArTiMist^® oral spray.

Key Management Changes in FY 2019-2020

During the past financial year, SUDA also made some key changes in its senior management, as stated below:

• Appointed Dr Michael Baker as the Chief Executive Officer (CEO) of SUDA, replacing the former Managing Director and CEO, Mr Stephen Carter.
• Appointed Mr Paul Hopper as the Interim Executive Chairman.

Additionaly, Mr Andrew Curtis, who was employed to lead US based business development activities left SUDA in December 2019.

Developments Subsequent to FY 2019-2020

On the financial front, SUDA reported a consolidated loss of ~$9.9 million for FY 2019-2020, which incorporates an impairment loss of ~$5.3 million for ArTiMist^®.

Subsequent to the financial year ended 30^th June 2020, SUDA attained TGA approval for registration of ZolpiMist^TM for the treatment of short-term insomnia in adults. The TGA’s approval provided SUDA with the following potential benefits:

• Inclusion of ZolpiMist^TM on the Australian Register of Therapeutic Goods, enabling the product to be commercialised and supplied within Australia;
• Exhibiting the Company’s compliance with Good Manufacturing Practice and its potential to attain regulatory approvals for its products;
• Assisting the Company’s existing partners in their submissions in their corresponding territories with the amended Active Pharmaceutical Ingredient (API) supplier and manufacturer.

In addition, SUDA also announced a 1 for 1 non renounceable entitlement offer to raise ~$3.56 million in July this year, which closed heavily oversubscribed. Consequently, the Company raised an additional $0.5 million through a placement to sophisticated investors.

Way Ahead

SUDA shares traded $0.050 on 31 August 2020.